Systems and methods for internal bone fixation

ABSTRACT

Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. A device for use in repairing a fractured bone includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein the delivery catheter has an inner void for passage of at least one reinforcing material and an inner lumen for passage of a light source; a conformable member releasably engaging the distal end of the delivery catheter, wherein the conformable member moves from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member; and an adapter releasably engaging the proximal end of the delivery catheter for receiving the light source and the at least one reinforcing material.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/535,913, filed Nov. 7, 2014, now U.S. Pat. No. 9,717,542, which is acontinuation of U.S. application Ser. No. 13/730,521, filed on Dec. 28,2012, now U.S. Pat. No. 8,906,031, which is a continuation of U.S.application Ser. No. 12/858,924, filed on Aug. 18, 2010, now U.S. Pat.No. 8,366,711, which is a continuation of U.S. application Ser. No.11/903,123, filed on Sep. 20, 2007, now U.S. Pat. No. 7,811,284, whichclaims the benefit of U.S. Provisional Application Ser. No. 60/858,202,filed Nov. 10, 2006 and U.S. Provisional Application Ser. No.60/880,646, filed Jan. 16, 2007, and the entirety of these applicationsare hereby incorporated herein by reference for the teachings therein.

FIELD

The embodiments disclosed herein relate to medical devices for use inrepairing a weakened or fractured bone, and more particularly tointernal bone fixation devices and methods of using these devices forrepairing a weakened or fractured bone.

BACKGROUND

Fracture repair is the process of rejoining and realigning the ends ofbroken bones. Fracture repair is required when there is a need forrestoration of the normal position and function of the broken bone.Throughout the stages of fracture healing, the bones must be held firmlyin the correct position and supported until it is strong enough to bearweight. In the event the fracture is not properly repaired, malalignmentof the bone may occur, resulting in possible physical dysfunction of thebone or joint of that region of the body.

Until the last century, physicians relied on casts and splints tosupport the bone from outside the body (external fixation). However, thedevelopment of sterile surgery reduced the risk of infection so thatdoctors could work directly with the bone and could implant materials inthe body. Currently there are several internal approaches to repair,strengthen and support a fractured bone. They include the use ofinternal fixation devices, such as wires, plates, rods, pins, nails, andscrews to support the bone directly, and the addition of bone cementmixtures, or bone void fillers to a fractured bone.

The addition of bone cements to a fractured bone for repairing bone and,for example, joining bones are well known in the art. Conventional bonecement injection devices have difficulty adjusting or controlling theinjection volume or injection rate of the bone cement in real time inreaction to cancellous bone volume and density conditions encounteredinside the fractured bone. Conventional bone cements also may causecomplications that include the leakage of the bone cement to an areaoutside of the fractured bone site, which can result in soft tissuedamage as well as nerve root pain and compression.

Thus, there is a need in the art for internal bone fixation devices thatrepair, strengthen and support a fractured bone using minimally invasivetechniques, with ease of use, and minimal damage to the bone andsupporting tissues.

SUMMARY

Internal bone fixation devices and methods for using the devices forrepairing a weakened or fractured bone are disclosed herein. Accordingto aspects illustrated herein, there is provided an internal bonefixation device that includes a conformable member; and at least onereinforcing material contained within the conformable member, whereinthe conformable member moves from a deflated state to an inflated statewhen the at least one reinforcing material is added to the conformablemember.

According to aspects illustrated herein, there is provided a device foruse in repairing a fractured bone that includes a delivery catheterhaving an elongated shaft with a proximal end, a distal end, and alongitudinal axis therebetween, wherein the delivery catheter has aninner void for passage of at least one reinforcing material and an innerlumen for passage of a light source; a conformable member releasablyengaging the distal end of the delivery catheter, wherein theconformable member moves from a deflated state to an inflated state whenthe at least one reinforcing material is delivered to the conformablemember; and an adapter releasably engaging the proximal end of thedelivery catheter for receiving the light source and the at least onereinforcing material.

According to aspects illustrated herein, there is provided a method forrepairing a fractured bone that includes gaining access to an innercavity of the fractured bone; providing a device for use in repairingthe fractured bone, the device comprising a conformable memberreleasably engaging a delivery catheter, wherein the delivery catheterhas an inner void for passage of at least one reinforcing material tothe conformable member and an inner lumen for passage of a light sourceto the conformable member; positioning the conformable member spanningat least two bone segments of the fractured bone; inserting a lightsource into the inner lumen of the device; adding at least onereinforcing material to the inner void of the device; infusing the atleast one reinforcing material through the inner void of the deliverycatheter to the conformable member, wherein the conformable member movesfrom an initial deflated state to a final inflated state; activating thelight source to harden the at least one reinforcing material in theinflated conformable member; and releasing the hardened conformablemember from the delivery catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 shows a perspective view of a device for repairing a weakened orfractured bone of the presently disclosed embodiments.

FIG. 2A and FIG. 2B show perspective views of a device for repairing aweakened or fractured bone of the presently disclosed embodiments. FIG.2A shows a balloon portion of the device in a deflated state. FIG. 2Bshows a balloon portion of the device in an inflated state.

FIG. 3A and FIG. 3B show close-up views of some of the main componentsof a device for repairing a weakened or fractured bone of the presentlydisclosed embodiments. FIG. 3A shows a perspective view of a distal endof the device. FIG. 3B shows a side cross-sectional view taken alongline A-A of the device.

FIG. 4 shows a perspective view of a light source for use with a devicefor repairing a weakened or fractured bone of the presently disclosedembodiments.

FIG. 5A and FIG. 5B show cross-sectional views of a device for repairinga weakened or fractured bone of the presently disclosed embodiments.FIG. 5A shows a side cross-sectional view of the device. FIG. 5B shows across-sectional view of the device.

FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D and FIG. 6E shows the method stepsfor utilizing a device of the presently disclosed embodiments for repairof a fractured bone.

FIG. 7A, FIG. 7B and FIG. 7C show illustrative embodiments of afractured metacarpal bone in a finger of a hand.

FIG. 8A, FIG. 8B and FIG. 8C shows a device of the presently disclosedembodiments used for internal bone fixation. FIG. 8A shows the placementof the device at a metacarpal fracture in a hand of a patient. FIG. 8Bshows a side view of a balloon portion of the device as the balloonportion is inflated with a reinforcing material to repair the fracture.FIG. 8C shows a side view of the balloon portion at the site of the bonefracture after the balloon portion has been released from the device.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Medical devices and methods for repairing a weakened or fractured boneare disclosed herein. The devices disclosed herein act as internal bonefixation devices and include a delivery catheter terminating in areleasable conformable member. During a procedure for repairing afractured bone, the conformable member is placed within an inner cavityof a fractured bone n a deflated state. Once in place, the conformablemember is expanded from a deflated state to an inflated state by theaddition of at least one reinforcing material. The at least onereinforcing material is subsequently hardened within the conformablemember using a light source. The hardened conformable member may then bereleased from the delivery catheter and sealed to enclose the at leastone reinforcing material within the conformable member. The hardenedconformable member remains within the inner cavity of the fractured boneand provides support and proper orientation of the fractured boneresulting in the repair, healing, and strengthening of the fracturedbone.

Reinforcing materials include, but are not limited to, bone reinforcingmixtures (such as bone cement mixtures, bone void fillers, epoxies,glues and similar adhesives), orthopedic wires, stainless-steel rods,metal pins, and other similar devices. The reinforcing material may be anatural or synthetic material for strengthening, replacing, orreinforcing of bones or bone tissue. Bone reinforcing mixtures includeglues, adhesives, cements, hard tissue replacement polymers,biodegradable polymers such as PLA, PGA, and PLA-PGA copolymers, naturalcoral, hydroxyapatite, beta-tricalcium phosphate, and various otherbiomaterials known in the art for strengthening, replacing orreinforcing bones. As inert materials, bone reinforcing mixtures may beincorporated into surrounding tissue or gradually replaced by originaltissue. Those skilled in the art will recognize that numerous bonereinforcing mixtures known in the art are within the spirit and scope ofthe presently disclosed embodiments.

A device disclosed herein may be used for the repair of bones that haveweakened or fractured due to any of the bone diseases including, but notlimited to osteoporosis, achondroplasia, bone cancer, fibrodysplasiaossificans progressiva, fibrous dysplasia, legg calve perthes disease,myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia,osteoporosis, Paget's disease, scoliosis, and other similar diseases. Adevice disclosed herein may be used for the repair of bones that haveweakened or fractured due to an injury, for example, a fall.

Although some of the figures show the fractured bone as a metacarpalbone in the hand, those skilled in the art will recognize that thedisclosed devices and methods may be used for repairing other bonesincluding, but not limited to, the femur, tibia, fibula, humerus, ulna,radius, metatarsals, phalanx, phalanges, ribs, spine, vertebrae,clavicle and other bones and still be within the scope and spirit of thedisclosed embodiments.

The main components of a device for repairing a weakened or fracturedbone are shown generally in FIG. 1 in conjunction with FIG. 2A and FIG.2B. The device 100 includes a delivery catheter 110 having an elongatedshaft 101 with a proximal end 102, a distal end 104, and a longitudinalaxis therebetween. In an embodiment, the delivery catheter 110 has adiameter of about 3 mm. The distal end 104 of the delivery catheter 110terminates in a releasable conformable member 103. In an embodiment, theconformable member is a balloon portion. The balloon portion 103 maymove from a deflated state (FIG. 2A) to an inflated state (FIG. 2B) whenat least one reinforcing material is delivered to the balloon portion103. In an embodiment, the balloon portion 103 has a deflated diameterof about 2.5 mm. In an embodiment, the balloon portion 103 has aninflated diameter ranging from about 4 mm to about 9 mm. The reinforcingmaterial may be delivered to the balloon portion 103 via an inner voidcapable of allowing the reinforcing material to pass through. In anembodiment, a reinforcing material, such as UV-activated glue, is usedto inflate and deflate the balloon portion 103. In an embodiment, theballoon portion 103 may be round, flat, cylindrical, oval, rectangularor another shape. The balloon portion 103 may be formed of a pliable,resilient, conformable, and strong material, including but not limitedto urethane, polyethylene terephthalate (PET), nylon elastomer and othersimilar polymers. In an embodiment, the balloon portion 103 isconstructed out of a PET nylon aramet or other non-consumable materials.PET is a thermoplastic polymer resin of the polyester family that isused in synthetic fibers. Depending on its processing and thermalhistory, PET may exist both as an amorphous and as a semi-crystallinematerial. Semi-crystalline PET has good strength, ductility, stiffnessand hardness. Amorphous PET has better ductility, but less stiffness andhardness. PET can be semi-rigid to rigid, depending on its thickness,and is very lightweight. PET is strong and impact-resistant, naturallycolorless and transparent and has good resistance to mineral oils,solvents and acids.

In an embodiment, the balloon portion 103 is designed to evenly contactan inner wall of a cavity in a bone. In an embodiment, the balloonportion 103 may have a pre-defined shape to fit inside the cavity in aparticularly shaped bone. For example, as depicted in the embodiment ofFIG. 1, the pre-defined shape of the balloon portion 103 may be anelongated cylinder. The balloon portion 103 has a proximal end 123, adistal end 121 and a longitudinal axis therebetween having an outersurface 122. In an embodiment, the outer surface 122 of the balloonportion 103 is substantially even and smooth and substantially mateswith a wall of the cavity in the bone. In an embodiment, the outersurface 122 of the balloon portion 103 is not entirely smooth and mayhave some small bumps or convexity/concavity along the length. In someembodiments, there are no major protuberances jutting out from the outersurface 122 of the balloon portion 103. The balloon portion 103 may bedesigned to remain within the cavity of the bone and not protrudethrough any holes or cracks in the bone. In an embodiment, the outersurface 122 of the balloon portion 103 may be flush with the wall of thecavity and when the balloon portion 103 is inflated, the outer surface122 may contact the wall of the cavity along at least a portion of thesurface area. In an embodiment, when the balloon portion 103 isinflated, a majority or all of the balloon's 103 outer surface 122 doesnot contact the wall of the cavity and does not extend through any holesor cracks in the bone.

The outer surface 122 of the balloon portion 103 may be coated withmaterials such as drugs, bone glue, proteins, growth factors, or othercoatings. For example, after a minimally invasive surgical procedure aninfection may develop in a patient, requiring the patient to undergoantibiotic treatment. An antibiotic drug may be added to the outersurface 122 of the balloon portion 103 to prevent or combat a possibleinfection. Proteins, such as, for example, the bone morphogenic proteinor other growth factors have been shown to induce the formation ofcartilage and bone. A growth factor may be added to the outer surface122 of the balloon portion 103 to help induce the formation of new bone.Due to the lack of thermal egress of the reinforcing material in theballoon portion 103, the effectiveness and stability of the coating ismaintained.

In an embodiment, the outer surface 122 of the balloon portion 103 mayhave ribs, ridges, bumps or other shapes to help the balloon portion 103conform to the shape of a bone cavity. Balloons may be constructed toachieve transit within luminal cavities of bones and to expand,manipulate, and remove obstructions. In this way, the balloon portion103 may slide easier within the luminal bodies without coming in contactwith surrounding tissue. The balloon portion 103 may also be designed tobe placed in a bone and to grab a fractured bone without any slippageusing a textured surface with a variety of shapes such as small ridgesor ribs.

In an embodiment, a water soluble glue is applied to the outer surface122 of the balloon portion 103. When the balloon portion 103 is expandedand engages a moist bone, the water soluble glue on the outer surface122 of the balloon portion 103 becomes sticky or tacky and acts as agripping member to increase the conformal bond of the balloon portion103 to the bone. Once the balloon portion 103 is inflated, the outersurface 122 of the balloon portion 103 grips the bone forming amechanical bond as well as a chemical bond. These bonds prevent thepotential for a bone slippage. The water soluble glue may be cured byany light (e.g., UV not required).

In an embodiment, the balloon portion 103 has a textured surface whichprovides one or more ridges that allow grabbing all portions of bonefragments of a fractured bone. In an embodiment, ridges arecircumferential to the balloon portion 103 and designed to add more grabto the inflated balloon portion 103 on contact with the fractured bone.The ridges are also compressive so the ridges fold up on the fracturedbone when the balloon portion 103 is completely inflated. In anembodiment, sand blasted surfacing on the outer surface 122 of theballoon portion 103 improves the connection and adhesion between theouter surface 122 of the balloon portion 103 and the inner bone. Thesurfacing significantly increases the amount of surface area that comesin contact with the bone resulting in a stronger grip.

The balloon portion 103 of the device 100 typically does not have anyvalves. One benefit of having no valves is that the balloon portion 103may be inflated or deflated as much as necessary to assist in thefracture reduction and placement. Another benefit of the balloon portion103 having no valves is the efficacy and safety of the device 100. Sincethere is no communication passage of reinforcing material to the bodythere cannot be any leakage of material because all the material iscontained within the balloon portion 103. In an embodiment, a permanentseal is created between the balloon portion 103 that is both hardenedand affixed prior to the delivery catheter 110 being removed. Theballoon portion 103 may have valves, as all of the embodiments are notintended to be limited in this manner.

The balloon portion 103 of the delivery catheter 110 has a diameterranging from about 5 mm to about 9 mm. The balloon portion 103 of thedelivery catheter 110 has a length ranging from about 20 mm to about 80mm. In an embodiment, the balloon portion 103 has a diameter of about 5mm and a length of about 30 mm. In an embodiment, the balloon portion103 has a diameter of about 5 mm and a length of about 40 mm. In anembodiment, the balloon portion 103 has a diameter of about 6 mm and alength of about 30 mm. In an embodiment, the balloon portion 103 has adiameter of about 6 mm and a length of about 40 mm. In an embodiment,the balloon portion 103 has a diameter of about 6 mm and a length ofabout 50 mm. In an embodiment, the balloon portion 103 has a diameter ofabout 7 mm and a length of about 30 mm. In an embodiment, the balloonportion 103 has a diameter of about 7 mm and a length of about 40 mm. Inan embodiment, the balloon portion 103 has a diameter of about 7 mm anda length of about 50 mm.

A stiffening member 105 surrounds the elongated shaft 101 of thedelivery catheter 110 and provides rigidity over the elongated shaft101. A pusher or stabilizer 116 is loaded proximal to the balloonportion 103. A slip sleeve 107 surrounds the stiffening member 105. Inan embodiment, the slip sleeve 107 surrounds the stiffening member 105from the proximal end 123 of the balloon portion 103 up until the pusher116. One or more radiopaque markers or bands 130 may be placed atvarious locations along the balloon portion 103 and/or the slip sleeve107. A radiopaque ink bead 133 may be placed at the distal end 121 ofthe balloon portion 103 for alignment of the device 100 duringfluoroscopy. The one or more radiopaque bands 130, using radiopaquematerials such as barium sulfate, tantalum, or other materials known toincrease radiopacity, allows a medical professional to view the device100 using fluoroscopy techniques. The one or more radiopaque bands 130also provide visibility during inflation of the balloon portion 103 todetermine the precise positioning of the balloon portion 103 and thedevice 100 during placement and inflation. The one or more radiopaquebands 130 permit visualization of any voids that may be created by airthat gets entrapped in the balloon portion 103. The one or moreradiopaque bands 130 permit visualization to preclude the balloonportion 103 from misengaging or not meeting the bone due to improperinflation to maintain a uniform balloon/bone interface.

In an embodiment, an adapter 115, such as a Tuohy-Borst adapter, engagesthe proximal end 102 of the delivery catheter 110. A light source thatincludes a light pipe 152 may be introduced into one of the side-arms ofthe adapter 115 and passes within an inner lumen of the deliverycatheter 110 up until the distal end 104 of the delivery catheter 110.An adhesive system housing the reinforcing material may be introducedinto another side-arm of the adapter 115, as shown in FIG. 2B.Alternately, a Luer fitting may engage the proximal end 102 of thedelivery catheter 110 and a Luer fitting would exist on the light sourcesuch that the delivery catheter 110 and the light source would locktogether.

Examples of adhesive systems include, but are not limited to, caulkinggun type systems, syringe systems, bag systems that contain the bonereinforcing material where the delivery of the bone reinforcing materialis controlled using a tube clamp or any other restrictor valve. In theembodiment shown in FIG. 2B, the adhesive system is a syringe 160. In anembodiment, the syringe 160 has a control mechanism that regulates theflow of the reinforcing material. The control mechanism of the syringe160 allows the reinforcing material to flow into the delivery catheter110 and the flow may be stopped if desired. The syringe 160 makes directcontact to control the directional flow of the reinforcing material, andthe direction of flow of the reinforcing material instantaneouslychanges within the delivery catheter 110 in response to a change in thedirection of the syringe 160.

In an embodiment, the syringe 160 is opaque and does not allow light topenetrate within the syringe 160. Having an opaque syringe 160 ensuresthat the reinforcing material contained in the syringe 160 is notexposed to light and will not cure in the syringe 160. The reinforcingmaterial is of a liquid consistency, as measured in Centipoise (cP), theunit of dynamic viscosity, so the reinforcing material may be infusedfrom the syringe 160 into the delivery catheter 110 and into the balloonportion 103. Because the reinforcing material has a liquid consistencyand is viscous, the reinforcing material may be delivered using lowpressure delivery and high pressure delivery is not required, but may beused.

In an embodiment, a separation area is located at the junction betweenthe distal end 123 of the balloon portion 103 and the elongated shaft101. The separation area may also include an illumination band. Whenactivated, the illumination band causes light to cure the reinforcingmaterial located in the balloon portion 103 within the illuminationband. The illumination band extends around the delivery catheter 110 andhas a stress concentrator. The stress concentrator may be a notch,groove, channel or similar structure that concentrates stress in theillumination band. The stress concentrator of the illumination band maybe notched, scored, indented, pre-weakened or pre-stressed to directseparation of the balloon portion 103 from the elongated shaft 101 ofthe delivery catheter 110 under specific torsional load. The separationarea ensures that there are no leaks of reinforcing material from theelongated shaft of the delivery catheter and/or the balloon portion. Theseparation area seals the balloon portion and removes the elongatedshaft of the delivery catheter by making a break at a known orpredetermined site (e.g., a separation area). The separation area may bevarious lengths and up to about an inch long. When torque (twisting) isapplied to the delivery catheter 110, the elongated shaft 101 separatesfrom the balloon portion 103. The twisting creates a sufficient shear tobreak the residual reinforcing material and create a clean separation ofthe balloon/shaft interface. The illumination band may be connected tothe light source and may be activated by a separate switch. Having adistinct switch to activate the illumination band may help to preventinadvertent delivery of light from the light source to cure thereinforcing material. The activation of the illumination band seals theballoon portion and seals the end of the delivery catheter, and ensuresthat there is a “hard seal” of the reinforcing material at theillumination band allowing no reinforcing material to leak from theballoon portion or the delivery catheter.

FIG. 3A and FIG. 3B show close-up views of some of the main componentsof the device 100. One or more radiopaque markers or bands 130 areplaced at various locations along the slip sleeve 107 of the device 100.Those skilled in the art will recognize that radiopaque markers 130 mayalso be placed at various locations along the balloon portion 103. In anembodiment, the one or more radiopaque bands 130 are placed at intervalsof about 10 mm along the length of the slip sleeve 107. In anembodiment, a radiopaque ink bead 133 is placed at the distal end 121 ofthe balloon portion 103 for easy visualization and alignment of thedevice 100 by fluoroscopy during a repair procedure. The radiopaquemarkers 130 and radiopaque ink bead 133 are formed using radiopaquematerial such as barium sulfate, tantalum, or other materials known toincrease radiopacity. The radiopaque markers 130 provide visibilityduring inflation of the balloon portion 103 to determine the precisepositioning of the balloon portion 103 and the delivery catheter 110during placement and inflation. The radiopaque markers 130 permitvisualization of voids created by air that may be entrapped in theballoon portion 103. The radiopaque markers 130 permit visualization topreclude the balloon portion 103 from misengaging or not meeting thesurface of a bone due to improper inflation. Once the correctpositioning of the balloon portion 103 and delivery catheter 110 aredetermined, the proximal end of the delivery catheter 110 may beattached to a delivery system that contains a reinforcing mixture.

A cross-sectional view taken along line A-A of FIG. 3A is shown in FIG.3B. As shown in FIG. 3B, the elongated shaft 101 of the deliverycatheter 110 terminates in the balloon portion 103 having the outersurface 122. Within the elongated shaft 101 of the delivery catheter 110is a light pipe conduit 111 for accepting a light source (not shown). Avoid 113 for passage of a reinforcing material is formed between aninner surface 124 of the delivery catheter 110 and an outer surface 117of the light pipe conduit 111. A delivery system comprising thereinforcing material may be attached to a side arm of a Tuohy-Borstadapter that is engaged to a proximal end of the delivery catheter 110.The reinforcing material may pass through the void 113 of the deliverycatheter 110 and enter the balloon portion 103. The infusion of thereinforcing material causes the balloon portion 103 to inflate to adesired state. In an embodiment, the reinforcing material is infusedthrough the void 113 in the delivery catheter 110 to expand the balloonportion 103 to position a bone in a healing orientation. To establishthe healing orientation, the balloon portion 103 inflates until thebones move into an aligned orientation and are supported. Orientation ofthe bones may be done without any visualization of the process or usingx-ray or a fluoroscope. In an embodiment, a C arm imaging system is usedas part of a fluoroscope. The C arm imaging system may allow movement ormanipulation of the fluoroscope to rotate around tissue while viewing.Other techniques may be used for monitoring or inspecting the expansionof the balloon portion 103 such as magnetic resonance imaging (MRI),ultrasound imaging, x-ray fluoroscopy, Fourier transform infraredspectroscopy, ultraviolet or visible spectroscopy. The balloon portion103 may be composed of non ferromagnetic materials and, thus, iscompatible with MRI.

As shown in FIG. 3B, the outer slip sleeve 107 surrounds the stiffeningmember 105. The stiffening member 105 surrounds and provides rigidity tothe elongated shaft of the delivery catheter 110. The light pipe conduit111 provides a space for a light source to pass through. The void 113 isformed between the outer surface 117 of the light pipe conduit 111 andthe inner surface 124 of the delivery catheter 110. This void 113provides a passageway for the reinforcing material. The outer surface117 of the light pipe conduit 111 allows for a separation between thelight source and the reinforcing material.

FIG. 4 in conjunction with FIG. 1 shows a light source 150 for use withthe device 100 of the presently disclosed embodiments. The light source150 is used to harden the reinforcing material that has been infusedinto the balloon portion 103 of the delivery catheter 110. The lightsource 150 includes a light pipe 152 which terminates in an optical lens154. Energy emitted from the light pipe 152 is projected through theoptical lens 154 and guided into the balloon portion 103 of the deliverycatheter 110. The optical lens 154 may be convex, concave or planar. Theoptical lens 154 is curved to converge or diverge the transmitted energyfrom the light pipe 152. In an embodiment, the optical lens 154 is madeout of a plastic material such as Acrylic (PMMA), Polycarbonate (PC),Polystyrene (PS), or other similar materials known to those in the artsuch as Cyclic Olefin Copolymer (COC), and Amorphous Polyolefin(Zeonex). In an embodiment, the optical lens 154 is made out of a glassmaterial such as quartz.

The light source 150 is introduced into a side arm of the adapter 115that engages the proximal end 102 of the delivery catheter 110. Thelight source 150 runs through the elongated shaft 101 of the deliverycatheter 110 through the light pipe conduit and up into the proximal end123 of the balloon portion 103, as shown in FIG. 1. The activation ofthe light source 150 cures the reinforcing material resulting in theaffixing of the balloon portion 103 in an expanded shape. A cure mayrefer to any chemical, physical, and/or mechanical transformation thatallows a composition to progress from a form (e.g., flowable form) thatallows it to be delivered through the void in the delivery catheter 110,into a more permanent (e.g., cured) form for final use in vivo. Forexample, “curable” may refer to uncured composition, having thepotential to be cured in vivo (as by catalysis or the application of asuitable energy source), as well as to a composition in the process ofcuring (e.g., a composition formed at the time of delivery by theconcurrent mixing of a plurality of composition components).

In an embodiment, the reinforcing material is a light cure adhesive orultraviolet (UV) adhesive. Examples of light cured materials includethose commercially available from Loctite of Henkel Corporation, locatedin Rocky Hill, Conn. and those commercially available from DYMAXCorporation, located in Torrington, Conn. A benefit of UV curing is thatit is a cure-on-demand process and that adhesives may be free ofsolvents and include environmentally friendly resins that cure inseconds upon exposure to long wave UV light or visible light. DifferentUV adhesives use photoinitiators sensitive to different ranges of UV andvisible light. Being very energetic, UV light can break chemical bonds,making molecules unusually reactive or ionizing them, in generalchanging their mutual behavior. Visible light, for example, visible bluelight, allows materials to be cured between substrates that block UVlight but transmits visible light (e.g., plastics). Visible lightpenetrates through the adhesive to a greater depth. Since the visiblelight penetrates through the adhesive, curing of the adhesive increasesas a greater portion of the electromagnetic spectrum is available asuseful energy. Additives may be used with the UV adhesive deliverysystem, including, but not limited to drugs (for example, antibiotics),proteins (for example, growth factors) or other natural or syntheticadditives.

The electromagnetic spectrum is the range of all possibleelectromagnetic radiation. The electromagnetic spectrum of an object isthe frequency range of electromagnetic radiation that the object emits,reflects, or transmits. The electromagnetic spectrum extends from justbelow the frequencies used for modern radio (at the long-wavelength end)to gamma radiation (at the short-wavelength end), covering wavelengthsfrom thousands of kilometers down to fractions of the size of an atom.In an embodiment, the UV adhesive is a single-component, solvent-freeadhesive that will not cure until a UV light engages the adhesive, andwhen that occurs, the adhesive will cure in seconds to form a completebond with a shear strength. In an embodiment, the reinforcing materialexhibits a shrinkage upon cure of about 2 to about 3 percent.

UV light wavelength ranges from about 1 nm to about 380 nm, and can besubdivided into the following categories: near UV (380-200 nmwavelength; abbreviated NUV), far or vacuum UV (200-10 nm; abbreviatedFUV or VUV), and extreme UV (1-31 nm; abbreviated EUV or XUV).Similarly, visible light has a wavelength spectrum of between about 380to about 780 nm. Those skilled in the art will recognize that some UVadhesives may be activated by UV light, visible light, x-rays, gammarays, microwaves, radio waves, long waves or any light having awavelength less than about 1 nm, between about 1 nm and about 380 nm,between about 380 nm and about 780 nm, or greater than 780 nm, as notall embodiments are intended to be limited in that respect.

Using a UV light, the reinforcing material ensures there is no orminimal thermal egress and that the thermal egress may not be long induration. More specifically, there is no chemical composition or mixingof materials. Using the UV light to cure the reinforcing materialassists in holding broken bones in place, filling of the balloonportion, and viewing under a C arm imaging system. The reinforcingmaterials cure in such a way that is sufficient to hold a bone in thecorrect orientation. More specifically, the ability to inflate, set,adjust, orient bones, and the resulting union of the bone are availableprior to hardening the reinforcing material. The introduction of the UVlight starts the photoinitiator and the UV adhesive hardens. Once the UVlight is introduced, the adhesive inside the balloon portion hardens andthe adhesives inside are affixed in place. Until the UV light isintroduced, the bone placement is not disturbed or rushed as there is nohardening of the adhesives until the light is introduced, the balloonportion may be inflated or deflated due to the viscosity of theadhesive. The adhesive may be infused or removed from the balloonportion due to the low viscosity of the adhesive. In an embodiment, theviscosity of the reinforcing material has a viscosity of about 1000 cPor less. In an embodiment, the reinforcing material has a viscosityranging from about 650 cP to about 450 cP. Not all embodiments areintended to be limited in this respect and some embodiments may includereinforcing materials having a viscosity exactly equal to or greaterthan 1000 cP. In an embodiment, a contrast material may be added to thereinforcing material without significantly increasing the viscosity.Contrast materials include, but are not limited to, barium sulfate,tantalum, or other contrast materials known in the art.

Several epoxies known in the art are suitable for use as bonereinforcing materials and vary in viscosity, cure times, and hardness(durometer or shore) when fully cured. A durometer of a materialindicates the hardness of the material, defined as the material'sresistance to permanent indentation. Depending on the amount ofresultant support that is necessary for a given bone fracture, aspecific durometer UV adhesive may be chosen. Alternately, multiple UVadhesives having varying durometers may be chosen for the repair of abone fracture and be within the scope and spirit of the presentlydisclosed embodiments. The durometer of a material may be altered toachieve either greater rigidity or a more malleable result. Themechanical properties of the epoxies may dictate using methods/measuresthat are typical for high-strength and high-impact materials includingbut not limited to, tensile strength and tensile modulus, tensilestrength tests, ultimate modulus, Poisson's ratio, hardness measurementslike Vickers and Charpy Impact which measures yield strength andtoughness.

In an embodiment, the reinforcing material is cured by chemicalactivation or thermal activation. Chemical activation includes but isnot limited to water or other liquids. In an embodiment, the reinforcingmaterial is a drying adhesive which has a polymer dissolved in a solventsuch that as the solvent evaporates, the adhesive hardens. In anembodiment, the reinforcing material is a hot or thermoplastic adhesivesuch that as the adhesive cools, the adhesive hardens.

The reinforcing material is not limited to the embodiments describedherein and may be any material that reinforces the bone. Some materialsmay require or be enhanced by curing via any means, such as UV orvisible light, heat, and/or addition or removal of a chemical orsubstance, may utilize any outside or internal processes to cure thematerial, or may not require curing.

In an embodiment, carbon nanotubes (CNTs) are added to the reinforcingmaterial to increase the strength of the material. Carbon nanotubes arean allotrope of carbon that take the form of cylindrical carbonmolecules and have novel strength properties. Carbon nanotubes exhibitextraordinary strength. Nanotubes are members of the fullerenestructural family, which also includes buckyballs. Whereas buckyballsare spherical in shape, a nanotube is cylindrical with at least one endtypically capped with a hemisphere of the buckyball structure. Nanotubesare composed entirely of sp2 bonds, similar to those of graphite. Thisbonding structure, which is stronger than the sp3 bonds found indiamond, provides the molecules with their unique strength. Nanotubesnaturally align themselves into “ropes” held together by Van der Waalsforces. Single walled nanotubes or multi-walled nanotubes may be used tostrengthen the reinforcing materials.

FIG. 5A and FIG. 5B show cross-sectional views of the device 100 showingthe light source passing through the light pipe conduit 111 of thedelivery catheter 110. The light source includes the light pipe 152terminating in the optical lens 154. The light source is used to hardenthe reinforcing material that has been infused into the balloon portion103 of the delivery catheter 110. Energy emitted from the light pipe 152is projected through the optical lens 154 and guided into the balloonportion 103 of the delivery catheter 110. The optical lens 154 may beconvex, concave or planar. The optical lens 154 is curved to converge ordiverge the transmitted energy from the light pipe 152.

In an embodiment, a fracture repair process reinforces a weakened orfractured bone without exposing the bone through a traditional surgicalincision. The presently disclosed embodiments use a minimally invasiveapproach by making a minor incision to gain access to the bone.Minimally invasive refers to surgical means, such as microsurgical,endoscopic or arthroscopic surgical means, that can be accomplished withminimal disruption of the pertinent musculature, for instance, withoutthe need for open access to the tissue injury site or through minimalincisions. Minimally invasive procedures are often accomplished by theuse of visualization such as fiber optic or microscopic visualization,and provide a post-operative recovery time that is substantially lessthan the recovery time that accompanies the corresponding open surgicalapproach. Benefits of minimally invasive procedures include causing lesstrauma because there is minimal blood loss, a reduction in surgery andanesthetized time, shortened hospitalization, and an easier and morerapid recovery. In an embodiment, a bone fixator may be placed within anintramedullary cavity of a weakened or fractured bone. By restoring andpreserving bone structure, some of the presently disclosed embodimentspermit additional future treatment options.

FIGS. 6A-6E in conjunction with FIG. 1, illustrate the method steps forrepairing a fractured bone in a patient's body. A minimally invasiveincision (not shown) is made through the skin of the patient's body toexpose a fractured bone 602. The incision may be made at the proximalend or the distal end of the fractured bone 602 to expose the bonesurface. Once the bone 602 is exposed, it may be necessary to retractsome muscles and tissues that may be in view of the bone 602. As shownin FIG. 6A, an access hole 610 is formed in the bone by drilling orother methods known in the art. In an embodiment, the access hole 610has a diameter of about 3 mm to about 10 mm. In an embodiment, theaccess hole 610 has a diameter of about 3 mm.

The access hole 610 extends through a hard compact outer layer 620 ofthe bone into the relatively porous inner or cancellous tissue 625. Forbones with marrow, the medullary material should be cleared from themedullary cavity prior to insertion of the device 100. Marrow is foundmainly in the flat bones such as hip bone, breast bone, skull, ribs,vertebrae and shoulder blades, and in the cancellous material at theproximal ends of the long bones like the femur and humerus. Once themedullary cavity is reached, the medullary material including air,blood, fluids, fat, marrow, tissue and bone debris should be removed toform a void. The void is defined as a hollowed out space, wherein afirst position defines the most distal edge of the void with relation tothe penetration point on the bone, and a second position defines themost proximal edge of the void with relation to the penetration site onthe bone. The bone may be hollowed out sufficiently to have themedullary material of the medullary cavity up to the cortical boneremoved. There are many methods for removing the medullary material thatare known in the art and within the spirit and scope on the presentlydisclosed embodiments. Methods include those described in U.S. Pat. No.4,294,251 entitled “Method of Suction Lavage,” U.S. Pat. No. 5,554,111entitled “Bone Cleaning and Drying system,” U.S. Pat. No. 5,707,374entitled “Apparatus for Preparing the Medullary Cavity,” U.S. Pat. No.6,478,751 entitled “Bone Marrow Aspiration Needle,” and U.S. Pat. No.6,358,252 entitled “Apparatus for Extracting Bone Marrow.”

A guidewire (not shown) may be introduced into the bone 602 via theaccess hole 610 and placed between bone fragments 604 and 606 of thebone 602 to cross the location of a fracture 605. The guidewire may bedelivered into the lumen of the bone 602 and crosses the location of thebreak 605 so that the guidewire spans multiple sections of bonefragments. As shown in FIG. 6B, the balloon portion 103 of the device100 for repairing a fractured bone, which is constructed and arranged toaccommodate the guidewire, is delivered over the guidewire to the siteof the fracture 605 and spans the bone fragments 604 and 606 of the bone602. Once the balloon portion 103 is in place, the guidewire may beremoved. The location of the balloon portion 103 may be determined usingat least one radiopaque marker 130 which is detectable from the outsideor the inside of the bone 602. For example, as shown in the embodimentdepicted in FIG. 6, radiopaque markers 130, which are visible fromoutside of the body using x-ray or other detection means, are locatedalong both the balloon portion 103 and the slip sleeve 107 of thedelivery catheter 110 to help align and position the device 100. Oncethe balloon portion 103 is in the correct position within the fracturedbone 602, the device 100 is attached to a delivery system which containsa reinforcing material. The reinforcing material is then infused througha void in the delivery catheter 110 and enters the balloon portion 103of the device 100. This addition of the reinforcing material within theballoon portion 103 causes the balloon portion 103 to expand, as shownin FIG. 6C. As the balloon portion 103 is expanded, the fracture 605 isreduced. In an embodiment, the reinforcing material is a UV curable gluewhich requires a UV light source to cure the adhesive. In an embodiment,a central space may remain in the balloon portion 103 which may befilled in order to provide extra strength and support to the fracturedbone 602. An optical rod or similar device may be positioned in thecentral space and turned on or illuminated. An optical rod or similardevice can be made of fiber, silica, quartz, sapphire or similarmaterials. The UV light will then harden the UV curable glue in theballoon portion 103. The end of the optical rod may be cut and remain inthe balloon portion 103 to provide increased rigidity.

Once orientation of the bone fragments 604 and 606 are confirmed to bein a desired position, the UV curable glue may be hardened within theballoon portion 103, as shown in FIG. 6D, such as by illumination with aUV emitting light source. After the UV curable glue has been hardened,the light source may be removed from the device 100. The balloon portion103 once hardened, may be released from the delivery catheter 110 byknown methods in the art. In an embodiment, the delivery catheter 110 iscut to separate the balloon portion 103 from the elongated shaft 101. Adevice slides over the delivery catheter 110 and allows a right anglescissor to descend through the delivery catheter 110 and make a cut. Thelocation of the cut may be determined by using a fluoroscope or anx-ray. In an embodiment, the cut location is at the junction where theelongated shaft 101 meets the balloon portion 103.

In an embodiment, the device 100 is used to treat a hand or wristfracture. The wrist is a collection of many joints and bones that allowuse of the hands. The wrist has to be mobile while providing thestrength for gripping. The wrist is complicated because every small boneforms a joint with its neighbor. The wrist comprises at least eightseparate small bones called the carpal bones, that connect the two bonesof the forearm, called the radius and the ulna, to the bones of the handand fingers. The wrist may be injured in numerous ways. Some injuriesseem to be no more than a simple sprain of the wrist when the injuryoccurs, but problems can develop years later. A hand fracture may occurwhen one of the small bones of the hand breaks. The hand consists ofabout 38 bones and any one of these bones may suffer a break. The palmor midhand is made up of the metacarpal bones. The metacarpal bones havemuscular attachments and bridge the wrist to the individual fingers.These bones frequently are injured with direct trauma such as a crushfrom an object or most commonly the sudden stop of the hand by a wall.The joints are covered with articular cartilage that cushions thejoints. Those skilled in the art will recognize that the discloseddevice and methods can be used for to treat fractures to other bones,such as radius, ulna, clavicle, metacarpals, phalanx, metatarsals,phalanges, tibia, fibula, humerus, spine, ribs, vertebrae, and otherbones and still be within the scope and spirit of the disclosedembodiments.

The presently disclosed embodiments may be used to treat a claviclefracture, resulting in a clavicle reduction. The clavicle or collar boneis classified as a long bone that makes up part of the shoulder girdle(pectoral girdle). Present methods to affix a broken clavicle arelimited. The clavicle is located just below the surface of the skin, sothe potential for external fixation including plates and screws islimited. In addition, the lung and the subclavian artery reside belowthe collar bone so using screws is not an attractive option. Traditionaltreatment of clavicle fractures is to align the broken bone by puttingit in place, provide a sling for the arm and shoulder and pain relief,and to allow the bone to heal itself, monitoring progress with X-raysevery week or few weeks. There is no fixation, and the bone segmentsrejoin as callous formation and bone growth bring the fractured bonesegments together. During healing there is much motion at the fractureunion because there is not solid union and the callous formation oftenforms a discontinuity at the fracture site. A discontinuity in thecollar bone shape often results from a clavicle fracture.

The presently disclosed embodiments and methods treat a claviclefracture in a minimally invasive manner and may be used for a claviclereduction or collar bone reduction. A benefit of using the discloseddevice to repair a collar bone is the repair minimizes post repairmisalignment of collar bone. A benefit of using the disclosed device torepair a clavicle is to resolve the patient's pain during the healingprocess.

FIGS. 7A, 7B and 7C, in conjunction with FIGS. 8A, 8B and 8C, show adevice 100 of the presently disclosed embodiments for use in repairing afractured metacarpal bone 702 in a finger 710 in a hand 700 of apatient. As shown, the fractured metacarpal bone 702 has been split intotwo fragments, 704 and 706, at a break site 705. As shown in FIG. 8A,the balloon portion of the device 100 is delivered to the site of thefracture 75 and spans the bone fragments 74 and 706 of the bone 702. Thelocation of the balloon portion may be determined using at least oneradiopaque marker which is detectable from the outside or the inside ofthe bone 702. Once the balloon portion is in the correct position withinthe fractured bone 702, the device 100 is attached to a delivery systemwhich contains a reinforcing material. The reinforcing material is theninfused through a void in the delivery catheter and enters the balloonportion of the device 100. This addition of the reinforcing materialwithin the balloon portion causes the balloon portion to expand, asshown in FIG. 8B. As the balloon portion is expanded, the fracture 705is reduced. In an embodiment, the reinforcing material is a UV curableglue which requires a UV light source to cure the adhesive. The UV lightwill then harden the UV curable glue in the balloon portion.

Once orientation of the bone fragments 704 and 706 are confirmed to bein a desired position, the UV curable glue may be hardened within theballoon portion, such as by illumination with a UV emitting lightsource. After the UV curable glue has been hardened, the light sourcemay be removed from the device 100. The balloon portion once hardened,may be released from the delivery catheter by known methods in the art,as shown in FIG. 8C. In an embodiment, the delivery catheter is cut toseparate the balloon portion from the elongated shaft.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art which arealso intended to be encompassed by the following claims.

What is claimed is:
 1. A device for repairing a bone comprising aballoon portion releasably engaging a distal end of a delivery catheter;and an inner lumen of the delivery catheter engaging the balloon portionsuch that a light energy can be delivered to the balloon portion to cureat least one reinforcing material curable by the light energy; whereinthe balloon portion is configured to move from a deflated state to aninflated state when the at least one reinforcing material is added intothe balloon portion such that the inflated state of the balloon portioncan be adjusted to orient the bone to a desired position by altering anamount of the at least one reinforcing material in the balloon portionby adding or withdrawing the at least one reinforcing material into andout of the balloon portion due to the viscosity of the reinforcingmaterial, the viscosity of the reinforcing material being 1000 cP orless, wherein the balloon portion is configured for placement into acavity of the bone.
 2. The device of claim 1, wherein the bone isselected from a group consisting of one of a metacarpal bone, femur,tibia, fibula, humerus, ulna, radius, metatarsals, phalanx, phalanges,ribs, spine, vertebrae or clavicle.
 3. The device of claim 1, whereinthe balloon portion is constructed to transit within the cavity of thebone.
 4. The device of claim 1, wherein the balloon portion does notextend through one or more hole, one or more crack or both, in the bone.5. The device of claim 1, wherein the balloon portion includes one ormore valves.
 6. The device of claim 1, wherein a radiopaque bead ispositioned at a distal end of the balloon portion for alignment of thedevice during fluoroscopy.
 7. The device of claim 1, wherein aseparation area is located at a junction between a distal end of aportion of the balloon portion and the elongated shaft and theseparation area includes a length up to about 1 inch.
 8. The device ofclaim 7, wherein the separation area includes an illumination bandextending around the delivery catheter and having a stress concentrator.9. The device of claim 1, wherein the inner lumen of the deliverycatheter is configured to engage the balloon portion to minimize thermalegress of the light energy to surrounding tissue from the balloonportion.
 10. The device of claim 1, further comprising an optical rodconfigured to extend through the inner lumen of the delivery catheter toguide the light energy into the balloon portion.
 11. A kit for repairinga weakened or fractured bone, the kit comprising: a delivery catheterhaving an elongated shaft with a proximal end, a distal end, and alongitudinal axis therebetween; a balloon portion designed to releasablyengage the delivery catheter; at least one reinforcing material curableby light energy configured to pass through an inner void of the deliverycatheter and into the balloon portion; and wherein the balloon portionis configured to move from a deflated state to an inflated state whenthe at least one reinforcing material is added into the balloon portionsuch that the inflated state of the balloon portion can be adjusted toorient the bone to a desired position by altering an amount of the atleast one reinforcing material in the balloon portion by adding orwithdrawing the at least one reinforcing material into and out of theballoon portion due to the viscosity of the reinforcing material, theviscosity of the reinforcing material being 1000 cP or less, thereinforcing material being curable by a light energy delivered throughthe catheter to the balloon.
 12. The kit of claim 11, further comprisinga light source for providing the light energy to a light pipe configuredto extend through an inner lumen of the delivery catheter into theballoon portion to guide the light energy into the balloon portion tocure the reinforcing material.
 13. The kit of claim 12, furthercomprising an adapter to be releasably engaged to the proximal end ofthe delivery catheter for receiving the light pipe and the at least onereinforcing material.
 14. The kit of claim 11, further comprising aplurality of balloon portions of varying sizes.
 15. The kit of claim 11,further comprising a device for cutting the balloon portion from thedelivery catheter.
 16. The kit of claim 11, wherein the inner lumen ofthe delivery catheter is configured to engage the balloon portion tominimize thermal egress of the light energy to surrounding tissue fromthe balloon portion.
 17. A method for repairing a weakened or afractured bone comprising: positioning a balloon portion releasablyengaging a delivery catheter within a cavity of the bone, wherein thedelivery catheter has an inner void for passage of a light cure adhesiveto the balloon portion and an inner lumen for passage of a light energyto the balloon portion; expanding the balloon portion by infusion of thelight cure adhesive into the inner void of the delivery catheter andinto the balloon portion; adjusting the expanded state of the balloonportion to orient bone to a desired position by altering an amount ofthe light cure adhesive in the balloon portion by adding or withdrawingthe light cure adhesive into and out of the balloon portion due to theviscosity of the light cure adhesive, the viscosity of the light cureadhesive being 1000 cP or less; and delivering light energy into theballoon portion to cure the light cure adhesive within the balloonportion.
 18. The method of claim 17, further comprising determining aposition of the balloon portion and an expansion of the balloon portionwithin the cavity of the bone by monitoring one or more radiopaquemarkers on the balloon portion.
 19. The method of claim 17, wherein theinner lumen engages the balloon portion to minimize thermal egress oflight energy to surrounding tissue from the balloon portion.
 20. Themethod of claim 17, further comprising inserting an optical rod throughthe inner lumen of the delivery catheter and into the balloon portion toguide the light energy therein.